From Acute to Chronic Postoperative Pain in Patients for Elective Cholecystectomy. Immunological Tests

NCT ID: NCT01546480

Last Updated: 2014-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-02-28

Brief Summary

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Chronic Pain after Cholecystectomy is a well known problem. One theory is that it is due to persisting inflammation.

The purpose of the study is to measure inflammatory factors in cerebrospinal fluid and blod at patients 12 months after the operation.

DNA-samples are collected to examine genetical factors, important for perception of pain, and the development of chronic pain.

Detailed Description

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Conditions

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Pain

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Pain patients

Patients with unexplained chronic abdominal pain 12 months after elective cholecystectomy

No interventions assigned to this group

Operated painfree Patients

Painfree patients 12 months after elective cholecystectomy

No interventions assigned to this group

Nonoperated painfree patients

Painfree patients with no previous abdominal operation

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Unexplained abdominal pain 12 months after elective cholecystectomy


* No pain 12 months after elective cholecystectomy


* Elective operation in spinal anesthesia or
* Or healthy volunteers accepting samples of blod, cerebral spinal fluid and saliva, to be collected

Exclusion Criteria

* Immunosuppressive treatment (NSAID excepted)
* Anticoagulant treatment

Group 2:


* Immunosuppressive treatment (NSAID excepted)
* Anticoagulant treatment

Group 3:


* Acute or chronic pain condition
* Immunosuppressive treatment (NSAID excepted)
* Previous abdominal operation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vejle Hospital

OTHER

Sponsor Role collaborator

Oberstinde Kirsten Jensa la Cours Foundation

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Morten Rune Eckhardt

Afdelingslæge

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Odense University Hospital

Odense, , Denmark

Site Status

Lillebælt Hospital

Vejle, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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119

Identifier Type: OTHER

Identifier Source: secondary_id

ImmT

Identifier Type: -

Identifier Source: org_study_id

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